3 Intrductin The mhealth Regulatry Calitin (referred t subsequently as the Calitin) is cmprised f industry representatives that manufacture and distribute the fundamental hardware and sftware used in mhealth * systems, healthcare prviders wh use mhealth technlgies t imprve healthcare delivery, and nn prfit rganizatins that advcate n behalf f patients and prviders fr the use f mhealth in the United States. In this whitepaper, the Calitin analyzes tw fundamental questins: (1) what mhealth hardware and sftware will the U.S. Fd & Drug Administratin (subsequently referred t as the FDA r the Agency) regulate and (2) if such prducts are regulated, in what device classificatin will the FDA place them? The three device classificatins determine, amng ther things, whether a given prduct requires sme srt f premarket clearance r apprval frm the FDA. The Calitin tackles these questins because, quite simply, the answers are fundamental t the business planning prcess and cmpanies as well as investrs need answers as sn as pssible t maintain innvatin. The Calitin wrte this whitepaper after having spent nearly five mnths meeting internally, and with entrepreneurs and established cmpanies alike, t learn abut their mhealth business plans. Thrugh this prcess, we identified the specific pen questins t determine whether the FDA wuld regulate their prducts and any applicable classificatin. The Calitin s missin is t drive the analysis t a level f specificity that wuld be meaningful t the FDA. Imprtantly, this whitepaper des nt attempt t slve these prblems. Rather, the Calitin fcuses n defining the myriad f prblems and challenges that arise when attempting t apply current FDA plicies and requirements t the future landscape f mhealth technlgies. The Calitin believes that bth the mhealth industry and the Agency must first clearly define the issues befre we can reslve them. The gal f the mhealth Regulatry Calitin is t wrk with the FDA t develp and draft a guidance dcument that addresses the regulatin f mhealth technlgies, specifically identifying what aspects f mhealth are nt regulated by the Agency. We believe that the develpment f a guidance dcument will bring greater clarity and predictability t the regulatry pathway fr the numerus hardware and sftware cmpnents n which mhealth technlgies rely. Thrugh active engagement with the FDA in this prcess, the mhealth Regulatry Calitin in alignment with the Agency s dual mandates hpes t fster innvatin while ensuring the safety and effectiveness f the prducts that will drive the future f the American healthcare system. This whitepaper mves us ne step clser t cmpleting ur gal, by ensuring a cmmn understanding f the nature and cnturs f the prblem. By the end f the first quarter f 2011, we intend t prepare a guidance dcument that prpses slutins t the questins presented here. * The m in mhealth is an abbreviatin fr mbile t recgnize the the integratin f mbile technlgy in healthcare tday. i

5 decisin supprt sftware running remtely and accessed thrugh a netwrk cnnectin using data cllected frm mhealth devices. Everyne including the FDA wants t see innvatin in mhealth. T see 1,000 ideas blssm, hwever, industry needs sme clarity regarding the scpe f the FDA s requirements ging frward in each f these areas. Business peple simply have t knw whether cmpliance with the FDA regulatins needs t be part f their plan. Clarity and predictability are critical t cntinued innvatin in mhealth. The FDA has previusly annunced that it is wrking n its wn guidance dcument t ffer sme general advice n hw mhealth apps are regulated, including what needs t be in a premarket submissin. It is difficult t predict when new plicy will emerge frm the Agency. As anyne wh has fllwed the prpsed medical device data system rule knws, it can take years. The Calitin s hpe is that the FDA will find this whitepaper useful in mving that prcess alng. entered by the patient and can incrprate data frm bth EMRs and EHRs. We use these terms in accrdance with the definitins abve. iii

6 Executive Summary This whitepaper utlines the myriad f specific questins that underlie tw fundamental questins: (1) what mhealth hardware and sftware will the U.S. Fd & Drug Administratin (FDA) regulate and (2) if such prducts are regulated, in what device classificatin will the FDA place them? Many f the questins arise because certain FDA plicies were written decades ag at a time when ur understanding f the cnnectins between lifestyle and disease were nt well understd. This is nt the first time the FDA has cnfrnted such a challenge. In the early 1990s when scientists began t understand better the cnnectins between dietary supplements and health, initially the FDA tried t regulate thse supplements as drugs. At the time, the FDA s plicies required that any health claims assciated with ingested prducts triggered drug status. Frtunately, Cngress and the FDA came up with a mre nuanced regulatry slutin that allwed dietary supplements t be brught t market withut filing a new drug applicatin. A very significant number f mhealth prducts appear designed t help cnsumers make better chices in their lifestyles, thereby prmting healthy living. mhealth creates a cnnectin that gives peple better access t useful infrmatin when they need it wherever they are where they live, where they wrk and where they play. That access t infrmatin allws cnsumers t take mre cntrl f their lives and make better decisins n such things as diet, exercise and aviding cnditins that stress their health. Just as with dietary supplements, it must be recgnized that this new knwledge f cnnectins between lifestyle and health shuld nt cause innvative, lw risk prducts t becme ver regulated. At a high level, the Calitin s whitepaper fcuses n questins that arise in three areas: 1. T what extent can mhealth related prducts be excluded frm FDA regulatin by fcusing their marketing campaigns n general imprvements t cnsumer wellness, as ppsed t fcusing n the management r treatment f diseases such as diabetes and hypertensin? Fr example, wuld the hardware and sftware assciated with a system prmted fr peridic transmissin f a cnsumer s weight t his physician be a regulated medical claim r an unregulated wellness claim? What if the data are instead merely transmitted t a persnal health recrd nt assciated with any particular physician? The Calitin generated a set f similar questins that all require clarificatin f the fine line between treatment f disease and prmtin f wellness that defines FDA jurisdictin. 2. T what extent d mbile phnes and ther generic cmmunicatin hardware becme FDA regulated medical devices simply because they are prmted fr cnnectin t a medical device? Wuld a mbile phne manufacturer that des nthing mre than passively sell thrugh its nline stre a third party app designed t cnnect the mbile phne t a bld glucse meter cause the mbile phne t becme a regulated medical device? Wuld a mbile phne intended t be used t dwnlad data frm a pacemaker becme itself a Class III medical device and regulated t the highest degree? The FDA's s called accessry plicy that fr decades has held that any prduct intended t be cnnected t a medical device is regulated t the same degree as the medical device prduces sme illgical scenaris if applied literally in tday's cnnected health envirnment. iv

7 3. T what extent des the FDA regulate sftware apps that are intended t reside n mbile phnes, rdinary PCs, servers r perhaps in the clud if they functin t prvide cnnectins between cmmunicatin hardware and medical devices r as repsitries fr health data? Fr example, des the FDA intend t regulate persnal health recrds? Is a sftware app stred n a mbile phne regulated as a medical device if it asks the patient questins and transmits the patient's answers t a health care prvider? Des the FDA plan t regulate decisin supprt sftware residing n a physician's mbile phne that ffers a preliminary analysis f data received frm the patient? Wuld sftware that sends a dctr an alert based n changes in a cnsumer s weight require prir clearance frm the FDA? T what extent wuld sftware that the FDA intends t regulate require premarket ntificatin? It has been years since the FDA clarified its stance n the regulatin f sftware and tday s mhealth systems heavily rely n sftware fr a wide variety f functinality that requires clarity frm the FDA n the apprpriate level f regulatin. This whitepaper explains existing FDA plicy in these three areas, answers at least at a high level the few questins that can be answered, and mst imprtantly identifies the remaining pen questins. This paper lays the fundatin fr the develpment f a guidance dcument that we plan t prpse t the FDA, addressing the pen questins. Basically, the Calitin first had t agree n the scpe and nature f the prblem t be slved, and then t suggest slutins t this prblem. v

12 Figure 1.3: A Cnceptual Illustratin f a Platfrm as a Cmpnent f an mhealth System Users Sftware Applicatins Other Hardware & Sftware Platfrms Standard Interface Operating Sftware Operating Hardware Platfrm Structure The PC and the Mac are examples f tw platfrms in the general cmputing realm. The PC has a specific hardware cnfiguratin that uses Micrsft Windws as its perating system. The Mac has a separate and unique hardware cnfiguratin that wrks in cnjunctin with the MacOS perating system. The PC and the Mac are distinct cmputer platfrms that enable the use f ther hardware and sftware. Standardizatin f hardware cnnectins (e.g., USB 2.0 r Firewire) as well as standard wireless prtcls (e.g., WiFi r Bluetth) allw peripheral hardware cmpnents t cnnect t bth the PC and the Mac. Likewise, sftware develpers (e.g., Adbe, wh makes Acrbat and Phtshp) create applicatins that execute n bth cmputing platfrms. Unlike the standardizatin f hardware cnnectins, sftware designed fr these tw platfrms requires unique prgramming t functin prperly that is, ne versin must be created fr the PC and anther fr the Mac. The cncept f a platfrm already exists in the medical device industry. Pacemaker manufacturers, fr example, have created unique, prprietary platfrms that allw their devices t functin. When a patient presents t the healthcare facility fr a device checkup, the physician must use a manufacturerspecific device prgrammer that is designed t cmmunicate with the patient s device. The physician must use a separate prgrammer when a different patient presents t the healthcare facility with a pacemaker frm anther manufacturer. The sftware that the tw prgrammers use are unique t the manufacturer and may even be unique t the specific device as cmpared t ther devices made by the same manufacturer (in the same way that an ld PC might use Windws XP while a new PC might use Windws 7 as its perating system). In the new and evlving mhealth realm, the use f platfrms invlves cnnecting t ne r mre netwrks, which tday generally means eventually cnnecting t the Internet. It is thrugh these netwrk cnnectins that the value f the platfrm increases dramatically fr mhealth technlgy because f the ability t access new infrmatin r new web based sftware services frm ther surces. In the same way that sftware adds value t a piece f hardware by expanding the functinality f the physical device, the use f netwrk cnnectins and intercnnecting platfrms adds an additinal layer f functinality. This added layer mves mhealth technlgy frm the traditinal wrld f islated systems with independent platfrms t a system f systems envirnment where independent platfrms cmmunicate thrugh standard prtcls. 5

13 In its simplest frm, an mhealth system can be viewed frm the functinal perspective. That is t say that the cmpnents f an mhealth system can be viewed simply as a netwrk f intercnnecting: Input devices (e.g., sensrs, prbes, etc); Prcessing units (i.e., where analysis and algrithms run); and Display devices (i.e., where rendering f infrmatin ccurs). Figure 1.4: Functinal View f a Simplified mhealth System In this paradigm, regulatry plicy might fcus n the safety f certain hardware and sftware elements (e.g., the inherent risk f the sensr, r the utput f a particular algrithm), while the cmmunicatin technlgies and underlying netwrk infrastructure can be described with parameters such as the ability t reliably (i.e., within a specific prbability f errr) transfer infrmatin within a certain latency perid. Even frm this simplistic apprach, the platfrm cncept is integral t mhealth, as it will be impssible t determine precise cnfiguratins fr testing every cmpnent and ther variable acrss the entire spectrum f mhealth. Frm the previus descriptin f the architectural layers, the ptential different cmbinatins f medical devices, cmmunicatins technlgies, diagnstic/analytical applicatins, and the underlying netwrk infrastructure are nearly infinite. Althugh platfrms are nt a new cncept, they d represent challenges fr an mhealth technlgy regulated as a medical device, as current device requirements were develped in a time when medical use and cmpnents were much mre clearly defined, identified, and easily islated. In cntrast, the pwer f platfrms in delivering reliable functinality, cnsistent user interfaces, and new applicatins is matched nly by their ability t be fluid and malleable. Mrever, the bundaries are nt always clear and may change ver time. 6

15 Cnclusin The rapid develpment f mhealth technlgies and the diversity f the underlying cmpnents that cmprise this evlving industry present a number f significant pre and pst market questins regarding the rle f the FDA in regulating this space. T prmte clarity and cnsistency thrughut this whitepaper and ur future discussins with the FDA, we present a definitin f mhealth and describe what is within the scpe f this discussin. Specifically, we frm ur definitin f mhealth arund fur key elements: Medical Device Technlgies; Cmmunicatins Technlgies; Netwrk Infrastructure; and Sftware Technlgies. In the chapters t fllw, we elabrate n these fur key elements and present the uncertainties that mhealth technlgies face in light f the current legal and regulatry framewrk fr medical devices. Our purpse is t detail the nuances f the issue and the imprtance f develping a guidance dcument specific t mhealth technlgy. In this way, the mhealth Regulatry Calitin intends t supprt the Agency s effrts t develp the apprpriate guidance dcument that enables the FDA t fulfill its legal duty t prtect and prmte the public health. 8

16 Chapter 2 The Rle f Intended Uses in mhealth Regulatin The intended use f a prduct is a key factr in determining whether the prduct is subject t FDA regulatin as a medical device. Under the Fd, Drug, and Csmetic Act (the Act ), 8 fr a prduct t be a medical device it must be intended fr a medical purpse (e.g., diagnsing r treating a disease r health cnditin). This chapter fcuses n the particular challenges that FDA regulatrs, and the (ptentially) regulated industry, face in evaluating the intended uses fr mhealth prducts. Backgrund: Cnnecting Daily Activities, Wellness, and Disease Thrugh mhealth Often, even regulatry experts have truble determining the intended uses f mhealth prducts when the prduct is intended fr use in achieving a wellness utcme. Prducts fr wellness are nt regulated as medical devices, but it can be difficult t distinguish wellness frm medical purpses. Fr example, a wellness prduct that assists in weight management (which is intended t prmte general health) might be hard t distinguish frm a medical device that is intended t treat besity (which might serve the same general functin, but is intended t treat a specific health cnditin). Further cmplicating matters, mhealth prducts marketed by several different entities ften are merged tgether in many different ways by different manufacturers r by cnsumers, fr a variety f uses. The facts surrunding these intercnnected uses can be cmplex and als play a crucial rle in defining a given prduct s intended use. Cngress culd nt have reasnably cntemplated these issues when it first defined medical devices in At that time, mhealth applicatins were the stuff f science fictin, nt real life. The understanding f the interrelatinship amng daily living, wellness, and disease was nt as well develped, if at all, as it is tday. Hwever, Cngress did have the fresight t give the FDA authrity that allws it t respnd t new technlgies and new challenges, within the scpe f the Act, in a way that serves public health U.S.C a. See United States v. Article f Drug Bact Unidisk, 394 U.S. 784 (1969). 9

17 Figure 2.1: Then and Nw: Disease, Wellness, and mhealth The task ahead f us is nt unlike the task the Agency faced when dietary supplements became ppular. Prir t that, medical science did nt have a sphisticated understanding f all f the cnnectins between diet and health. As new dietary supplements were identified that imprved verall health, there was als much discussin abut their impact n specific diseases r cnditins. Fr instance, the FDA had t grapple with the questin f when a dietary supplement might, because f claims made, meet the definitin f a drug. Ultimately, in that instance, Cngress amended the Agency's statutry framewrk t allw citizens t make better and mre infrmed use f dietary supplements t imprve their health. Frtunately, in the mhealth area, we are nt at the pint where there is a need t mdify the statutes because the FDA already has within its discretin the ability t draw apprpriate lines f distinctin. Legal Framewrk: Intended Use Under the Act, a prduct meets the statutry definitin f a medical device, and thus becmes subject t FDA regulatin, if it is: [A]n instrument, apparatus, implement, machine, cntrivance, implant, in vitr reagent, r ther similar r related article, including any cmpnent, part, r accessry, which is... [either] intended fr use in the diagnsis f disease r ther cnditins, r in the cure, mitigatin, treatment, r preventin f disease, in man r ther animals... [r] intended t affect the structure r any functin f the bdy f man r ther animals [i.e., medical purpses ]. 10 The intended uses referred t in the Act are thse intended by the persns legally respnsible fr the labeling f devices (fr simplicity we refer t these persns as manufacturers, althugh in reality the legally respnsible persn might nt be the same as wh actually manufactured the prduct). 11 Furthermre, thse intended uses are evidenced by representatins accmpanying, and circumstances 10 Fd, Drug, and Csmetic Act 201(h) (emphasis added). 11 FDA Device Labeling Guidance #G91 1, Mar. 8, 1991, available at deviceregulatinandguidance/guidancedcuments/ucm htm. 10

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